Quality Control Analytical Associate III
Competitive Salary + Growth Opportunities!!!
A leading global pharmaceutical company that's committed to the advancement of Cell and Gene therapy, is expanding their Quality Control team to help transform the future of medicine!
The Quality Control Analytical Associate III will be reporting to the Manager of QC Analytical, serving as support to the clinical and commercial production to ensure quality standards are upheld through assisting with process check point, stability, and releasing analytical testing.
If you're looking for the step up in your career and have the drive to move forward, then apply for the position of Quality Control Analytical Associate III today!
Responsibilities
- Perform accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations
- Lead investigations for out-of-specification, out-of-trend, aberrant, and/or non-conforming test results
- Determine root causes and implement intelligent corrective and preventive actions (CAPAs) and monitor CAPA effectiveness
- Ensure timely issuance, review, and approval of Certificate of Analysis, alongside timely closures of batch records, deviations, and CAPA
- Initiate, assess, approve, track, and trend deviations, Change Controls and CAPAs.
- Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
- Assist in training Quality Control Analytical Associates
- Grow to serve as a lead and/or co-lead for client projects
- Manage and drive resolution of quality issues with clients, collaborators, and internal personnel
- Make informed and independent decisions on complex issues in collaboration with key stakeholders and alignment with company policies.
The ideal candidates will have:
- Bachelors in a Science or relevant field, Masters a big plus!
- 4-6 years of experience within a QC laboratory setting or within biopharmaceutical industry
- Academic or industrial experience with cell therapy
- QC Lab, clinical lab, microbiology, hematology, blood banking, or immunology experience in a cGMP/GTP environment
- Industry experience with cell count methodologies
- cGMP experience
Does this sound like you? Apply today!
